Paroxysmal and persistent atrial fibrillation ablation outcomes with the pulmonary vein ablation catheter GOLD duty-cycled phased radiofrequency ablation catheter: quality of life and 12-month efficacy results from the GOLD Atrial Fibrillation Registry

Aims The GOLD AF Registry has been designed to prospectively assess the population, indications, and outcomes using second-generation phased radiofrequency (RF) ablation (pulmonary vein ablation catheter GOLD) in a global examination of standard-of-care use for the treatment of paroxysmal and persistent atrial fibrillation (AF). Methods and results GOLD AF (NCT02433613) is a prospective, observational, multi-centre registry designed to characterize efficacy and safety of phased RF ablation in patients with AF. The primary endpoint was freedom from AF recurrence at 12-month follow-up after a 90-day blanking period. Ancillary objectives include safety, procedural efficiency, and quality of life (QoL). The QoL assessment using the Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) and the European Heart Rhythm Association (EHRA) Score of AF-related symptoms was collected at baseline and 12 months. In total, 1054 patients were included in this analysis (age 60.6, 67.6% male, 26.5% PersAF). Kaplan–Meier estimate of freedom from AF recurrence was 77.7% at 12 months. Peri-procedural device or procedure-related complications were observed in 26 (2.5%) patients, with a low stroke rate of 0.3%. One-year post-ablation, the EHRA AF Symptom score decreased in 68% of patients. The AFEQT score improvement was observed in 88.4% and 90.4% of patients who completed the questionnaire in-person or interviewed by phone at 12 month follow-up, respectively. Conclusion Phased RF ablation for the treatment of paroxysmal and persistent AF demonstrated a 77.7% freedom from AF recurrence at 12 months in addition to a significant reduction in arrhythmia symptoms and clinically meaningful improved QoL. Low peri-procedural complication rate of <3% was reported.

Atrial Fibrillation Ablation with Multipolar Phased-Radiofrequency Catheter: The Learning Curve Effect for Procedural Parameters, but not for the Long-Term Outcome

Background: Pulmonary vein isolation (PVI) is a routine treatment in atrial fibrillation (AF). Single-shot techniques were introduced to simplify the procedure. We analyzed time-dependent changes in procedural parameters, acute success, complication rates, and long-term outcomes during our initial experience with multipolar phased-radiofrequency (RF) ablation. Methods and Results: The first 126 consecutive patients (98 male; age: 58.8 ± 8.7 years) who underwent PVI with phased-RF ablation at our center were included in the study. Procedural parameters, complication rate, acute success and 12-month efficacy were compared in the first, second and third group of 42 consecutive patients. In all patients, 516/526 PVs were effectively isolated (98.1%), with no differences between the tierces (p = 0.67). Procedure (169.8 vs. 132.9 vs. 105.8 min, p < 0.0001), fluoroscopy (32.9 vs. 24.3 vs. 14.1 min, p < 0.0001) and left atrial dwell (83.0 vs. 61.9 vs. 51.4 min, p < 0.0001) times were significantly reduced with experience in tierces 1–3, respectively. In the 12-month follow-up, 60.3% of patients were arrhythmia-free with no differences between the tierces (p = 0.88). In multivariate analysis, the relapse in the blanking period (p < 0.0001), time from AF diagnosis (p = 0.004) and left atrial diameter (p = 0.012) were the only independent predictors of AF recurrence. Conclusions: The learning curve effect was demonstrated in procedural parameters, but not in the complication rate nor the long-term success of PVI with phased-RF technique. The relapse in the blanking period was the strongest predictor of treatment failure in long-time observation.